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U.S. FDA Medical Device Articulation Paper Requirements

FDA Medical Device Definition: Articulation paper is a device composed of paper coated with an ink dye intended to be placed between the patient's upper and lower teeth when the teeth are in the bite position to locate uneven or high areas

Registrar Corp assists Articulation Paper companies with:

  • FDA Articulation Paper Establishment Registration
  • FDA Articulation Paper Listing
  • FDA Articulation Paper Label Requirements and Exceptions
  • FDA Articulation Paper Import Information
  • FDA Articulation Paper Detentions (Articulation Paper Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Articulation Paper Manufacturers (Articulation Paper Suppliers)
       - Articulation Paper Distributors
       - Articulation Paper Processors
       - Articulation Paper Repackers
       - Articulation Paper Relabelers
       - Articulation Paper Exporters
       - Articulation Paper Importers
For more information about Articulation Paper Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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